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Motor Signature, Falls Risk, and Home-Based Interventions in Older Adults With Mild Cognitive Impairment

28. september 2022 opdateret af: Taipei Medical University
A single-blinded, randomized controlled trial is designed to compare the effects of social interaction, computerized cognitive training, lower extremity strengthening, and tai chi chuan on improving cognitive functions and gait/mobility and reducing falls among 228 subjects with mild cognitive impairment, in which the influence of adherence to the intervention programs will also be examined.

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

252

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Mau-Roung Lin, Professor
  • Telefonnummer: 6572 886-2-27361661
  • E-mail: mrlin@tmu.edu.tw

Studiesteder

      • Taipei, Taiwan, 110
        • Rekruttering
        • Taipei Medical University
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

65 år til 100 år (Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • At least 65 years old
  • Had a fall at least 3 months prior to the baseline assessment
  • Can ambulate independently
  • Has mild cognitive impairment

Exclusion Criteria:

  • Cannot ambulate independently and communicate with researchers
  • Have a major unstable cardiopulmonary disease (e.g., ischemic chest pain, shortness of breath, recurrent syncopal episodes, orthopnea, paroxysmal nocturnal dyspnea, palpitations, or tachycardia)
  • Have a contraindication to physical exercise (e.g., severe osteoarthritis or severe pulmonary hypertension)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Computerized cognitive training
The computerized cognitive training will take place at each participant's residence. Participants will be asked to practice at least 1 session a day for 6 months, and a session lasts for 60 minutes.
Attention, memory, speed of processing, and executive functioning.
Eksperimentel: Lower extremity strengthening

This exercise will comprise stretching, muscle strengthening, and balance training at increasing difficulty levels, tailored and supervised by a physical therapist, and will take place at a subject's residence or in the neighborhood once a week for 6 months.

Each session will last 60 min.

Hver session varer 60 min, bestående af 10 min opvarmning, 45 min træning og 5 min nedkøling.
Eksperimentel: Tai chi chuan
The 8-form Yang-style tai chi intervention will take place at a subject's residence or the neighborhood once a week for 6 months, and each session will last for 60 minutes.
Hver session varer 60 min, bestående af 10 min opvarmning, 45 min træning og 5 min nedkøling.
Ingen indgriben: Social interaction
Immediately after the baseline assessment, the care manager will visit the subject in this group once for comparability with the other two intervention groups.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mattis Dementia Rating Scale (MDRS)
Tidsramme: 12 months
The Mattis Dementia Rating Scale (MDRS) contains five cognitive domains of attention, initiation/perseveration, construction, conceptualization, and memory, which specifically assess concentration, verbal fluency, visuospatial skills, analogical reasoning, and short-term memory, with score ranges for these domains of 0~37, 0~37, 0~6, 0~39, and 0~25 points, respectively, and a total score range of 0~144 points.
12 months
modified Telephone Interview of Cognitive Status (TICS-M)
Tidsramme: 12 months
The modified Telephone Interview of Cognitive Status (TICS-M) consists of the date of the interview, age, phone number, immediate and delayed word list recall, counting backward, responsive naming, word opposites, and repetition, with a total score range of 0~50.
12 months
mobility
Tidsramme: 12 months
The timed up and go test requires subjects to rise from a standard chair, walk a distance of 3 m, turn, walk back to the chair, and sit down. The time to complete the timed up and go will be recorded.
12 months
balance
Tidsramme: 12 months
The Tinetti balance score ranges 0~26, with a higher score indicating a better balance ability.
12 months
falls
Tidsramme: 12 months
number of falls and multiple falls
12 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
depressive symptoms
Tidsramme: 12 months
Depressive symptoms will be assessed using the 15-item Geriatric Depression Scale.
12 months
fear of falling
Tidsramme: 12 months
Activities-specific Balance Confidence (ABC) scale assesses an individual's confidence in performing 16 common daily tasks without losing balance, and total scores of the ABC scale are determined by the accumulated average of each item score and range between 0 and 100, with lower scores indicating greater balance confidence.
12 months
activity of daily living (ADL)
Tidsramme: 12 months
The activity of daily living (ADL) scale consists of seven basic ADLs (self-feeding, self-dressing, grooming, walking, getting in/out of bed, bathing, and controlling the bladder) and seven instrumental ADLs (using a telephone, transporting oneself, shopping, preparing meals, doing housework, taking medication, and managing one's money). These items are graded as 0 points (inability), 1 point (needs some help), or 2 points (no help needed). The ADL score ranges from 0 to 28 points, with a lower score indicating greater activity disability.
12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Mau-Roung Lin, Professor, Taipei Medical University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. februar 2017

Primær færdiggørelse (Forventet)

24. januar 2023

Studieafslutning (Forventet)

24. januar 2023

Datoer for studieregistrering

Først indsendt

31. januar 2019

Først indsendt, der opfyldte QC-kriterier

12. februar 2019

Først opslået (Faktiske)

15. februar 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. oktober 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. september 2022

Sidst verificeret

1. januar 2022

Mere information

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